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FDA 510(k)

MEDICON Spinal Spreading Systems

K-Number: K161680 · 2017-03-24

ApplicantMedicon EG
Decision Date2017-03-24
Product CodeGZT
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MEDICON Spinal Spreading Systems is a medical device manufactured by Medicon EG. It received FDA 510(k) clearance on 2017-03-24 under approval number K161680. The device is classified under product code GZT. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDICON Spinal Spreading Systems?

MEDICON Spinal Spreading Systems is a medical device that received FDA 510(k) clearance on 2017-03-24. It is manufactured by Medicon EG. The 510(k) number is K161680.

When was MEDICON Spinal Spreading Systems approved by the FDA?

MEDICON Spinal Spreading Systems received FDA 510(k) clearance on 2017-03-24, under approval number K161680.

What company makes MEDICON Spinal Spreading Systems?

MEDICON Spinal Spreading Systems is manufactured by Medicon EG.

What is the FDA product code for MEDICON Spinal Spreading Systems?

The FDA product code for MEDICON Spinal Spreading Systems is GZT.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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